Download G/TBT/N/CAN/296 Page 1 World Trade Organization G/TBT/N/CAN

WORLD TRADE
G/TBT/N/CAN/296
21 January 2010
ORGANIZATION
(10-0315)
Committee on Technical Barriers to Trade
Original: English/
French
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6
1.
Member to Agreement notifying: CANADA
If applicable, name of local government involved (Article 3.2 and 7.2):
2.
Agency responsible: Department of Health
Name and address (including telephone and fax numbers, email and website
addresses, if available) of agency or authority designated to handle comments
regarding the notification shall be indicated if different from above: Canadian Enquiry
Point, 200-270 Albert Street, Ottawa, Ontario, Canada, K1P 6N7 Tel.: +1 613 238 3222,
Fax.: +1 613 569 7808, E-mail: [email protected]
3.
Notified under Article 2.9.2 [ X ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:
4.
Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable): Prescription status of
medicinal ingredients for human use (ICS : 11.220)
5.
Title, number of pages and language(s) of the notified document: Proposed Amendment
to the Food and Drug Regulations (Project No. 1624 — Schedule F) (5 pages, available in
English and French).
6.
Description of content: This notification announces the availability of a letter that provides
an opportunity for comment on the proposed addition of four medicinal ingredients to Part I
of Schedule F to the Food and Drug Regulations.
Description of the medicinal ingredients:
1. Eculizumab is used to treat patients with paroxysmal nocturnal hemoglobinuria, a rare
disorder characterized by episodes of red blood cell destruction and blood in the urine
occuring primarily at night. Individualized instructions or direct supervision by a practitioner
is required. The patient may also require routine laboratory monitoring. Eculizumab may
cause undesirable or severe side effects at normal therapeutic dosage levels.
2. Olmesartan medoxomil is used to lower blood pressure in patients in whom the cause of
high blood pressure is unknown. Olmesartan medoxomil works by acting on the naturally
occurring hormone in the body, angiotensin II which is actively involved in blood pressure.
Individualized instructions or direct supervision by a practitioner is required. The patient may
also require routine laboratory monitoring. Olmesartan medoxomil may cause undesirable or
severe side effects at normal therapeutic dosage levels.
. /.
G/TBT/N/CAN/296
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3. Romiplostim is a protein used to treat low blood platelet counts in patients with immune
thrombocytopenic purpura, a disease in which the bodys immune system destroys platelets in
the blood. Individualized instructions or direct supervision by a practitioner is required. The
patient may also require routine laboratory monitoring. Romiplostim may cause undesirable
or severe side effects at normal therapeutic dosage levels.
4. Ustekinumab is used to treat patients with moderate to severe chronic plaque psoriasis.
Psoriasis is an autoimmune disease that causes scaly red patches called plaques on the skin.
Individualized instructions or direct supervision by a practitioner is required. The patient may
also require routine laboratory monitoring. Ustekinumab may cause undesirable or severe side
effects at normal therapeutic dosage levels.
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides
with the risk factors associated with each medicinal ingredient. Oversight by a practitioner is
necessary to ensure that appropriate risk/benefit information is considered before the drug
containing the medicinal ingredient is administered and that the drug therapy is properly
monitored.
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections
C.01.041 to C.01.049 of the Food and Drug Regulations. Part I of Schedule F lists ingredients
that require a prescription for human use and for veterinary use. Part II of Schedule F lists
ingredients that require a prescription for human use, but do not require a prescription for
veterinary use if so labelled or if in a form unsuitable for human use.
7.
Objective and rationale, including the nature of urgent problems where applicable:
Protection of human health
8.
Relevant documents: Therapeutic Products Directorate (TPD) web site http://www.hcsc.gc.ca/dhp-mps/prodpharma/legislation/notice-avis/index-eng.php, Project No. 1624, letter
posted: 11 January 2010
9.
Proposed date of adoption:
Proposed date of entry into force:
Normally within 6 to 8 months from the posting
of the letter on the TPD web site.
On the date the measure is adopted.
10.
Final date for comments: 27 March 2010
11.
Text available from: National enquiry point [ X], or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body: The electronic
version of Project No. 1624 can be downloaded at:
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1624-eng.php
(English)
http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/project_projet_1624-fra.php
(French)